Trial Outcomes & Findings for Effects of Electronic Cigarettes on Nicotine Concentrations (NCT NCT01775787)

NCT ID: NCT01775787

Last Updated: 2017-11-30

Results Overview

To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 7-10 days
• Results posted on: 2017-11-30

Participant Flow

Participant milestones

Measure	Tobacco Flavor/ Tobacco & Menthol Flavor Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine	Tobacco & Menthol Flavor/Tobacco Flavor Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine)
First 7-10 Days STARTED	13	14
First 7-10 Days COMPLETED	12	8
First 7-10 Days NOT COMPLETED	1	6
Second 7-10 Days STARTED	12	8
Second 7-10 Days COMPLETED	12	6
Second 7-10 Days NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Tobacco Flavor/ Tobacco & Menthol Flavor Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine	Tobacco & Menthol Flavor/Tobacco Flavor Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine)
First 7-10 Days Adverse Event	0	1
First 7-10 Days family emergency	0	1
First 7-10 Days time commitment	0	2
First 7-10 Days concerns with using IV	1	2
Second 7-10 Days time commitment	0	1
Second 7-10 Days concerns with using IV	0	1

Baseline Characteristics

Effects of Electronic Cigarettes on Nicotine Concentrations

Baseline characteristics by cohort

Measure	Nicotine With Tobacco Flavor and With Tobacco & Menthol Flavor n=27 Participants Smokers were assigned to electronic cigarettes containing 18mg/mL of nicotine in either a tobacco flavor solution or a tobacco and menthol flavor solution and then switched to other flavor for an additional 7 to 10 days. Monitoring sessions occurred on the last day of trial period of each flavor.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 10.24 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7-10 days

Population: Nicotine Concentrations Before and 5 Minutes After Ecig Use were intended to be analyzed, regardless of flavor, as pre-specified in the study protocol,

To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.

Outcome measures

Measure	Tobacco Flavor n=20 Participants Subjects received tobacco flavored nicotine for 7-10 days	Tobacco & Menthol Flavor n=18 Participants Subjects received tobacco \& menthol flavored nicotine for 7-10 days
Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use Before Ecig used	4.30 ng/ml Standard Error .66	4.11 ng/ml Standard Error 1.23
Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use 5 minutes after ecig use	8.66 ng/ml Standard Error .08	8.77 ng/ml Standard Error 1.53

Adverse Events

Tobacco Flavor & Tobacco & Menthol Flavor (TOB Flavor)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Tobacco Flavor & Tobacco & Menthol Flavor (TOB/MENTH Flavor)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tobacco & Menthol Flavor & Tobacco Flavor (TOB/MENTH Flavor)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Tobacco & Menthol Flavor & Tobacco Flavor (TOB Flavor)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tobacco Flavor & Tobacco & Menthol Flavor (TOB Flavor) n=13 participants at risk AE occurred in intervention "Tobacco Flavor Session 17-10 days" Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine)	Tobacco Flavor & Tobacco & Menthol Flavor (TOB/MENTH Flavor) n=12 participants at risk AE occurred in intervention "Tobacco Flavor Session 27-10 days" Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine)	Tobacco & Menthol Flavor & Tobacco Flavor (TOB/MENTH Flavor) n=14 participants at risk AE occurred in intervention "Tobacco \& Menthol Flavor Session 17-10 days" Subjects randomized to Tobacco \& Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine)	Tobacco & Menthol Flavor & Tobacco Flavor (TOB Flavor) n=8 participants at risk AE occurred in intervention "Tobacco Flavor Session 2 7-10 days" Subjects randomized to Tobacco \& Menthol Flavor group 7-10 days, then crossed over to Tobacco Flavor for 7-10 days. Nicotine with Tobacco Flavor or Tobacco \& Menthol Flavor (18mg/mL nicotine)
General disorders Thoat itchy and cough	0.00% 0/13 • Period from Randomization to close of study	0.00% 0/12 • Period from Randomization to close of study	7.1% 1/14 • Period from Randomization to close of study	0.00% 0/8 • Period from Randomization to close of study
Product Issues Concerns with using IV	0.00% 0/13 • Period from Randomization to close of study	0.00% 0/12 • Period from Randomization to close of study	14.3% 2/14 • Period from Randomization to close of study	12.5% 1/8 • Period from Randomization to close of study
Social circumstances Time Commitment	0.00% 0/13 • Period from Randomization to close of study	0.00% 0/12 • Period from Randomization to close of study	14.3% 2/14 • Period from Randomization to close of study	12.5% 1/8 • Period from Randomization to close of study
Social circumstances Family Emergency	7.7% 1/13 • Period from Randomization to close of study	0.00% 0/12 • Period from Randomization to close of study	7.1% 1/14 • Period from Randomization to close of study	0.00% 0/8 • Period from Randomization to close of study

Additional Information

Dr. Cheryl Oncken

UConn Health

Phone: 860-679-3425

Email: oncken@uchc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place